Postmarket Surveillance Specialist

Primary Function of Position:
 
The Regulatory Post Market Surveillance Specialist – Technical Writer provides feedback to customers via Failure Analysis Letters.  Feedback includes a summary of failure analysis results, Instruction For Use (IFU) reminders, and recommendations for customer consideration.  Failure analysis letters can be written for all Intuitive products and platforms including the daVinci robotic assisted surgery system and Ion robotic assisted bronchoscopy system

Roles and Responsibilities:

This position has responsibility and authority for:

• Creation and distribution of failure analysis letters based on completed failure analysis results
• Managing failure analysis letters and backlog using software systems such as SAP and Trackwise
• Work with translation vendors, as required, for letters outside of US
• Provide clarification on failure analysis letter content when requested
• Escalate feedback, comments, or concerns from customers or distributors based on failure analysis letters provided to end user
• Escalate complaints to the Post Market Investigation (PMI) group as required
• Interface with Failure Analysis, Customer Service, engineering, RMA, and clinical teams to gather information required for failure analysis letter content
• Maintain library of similar responses in reference to failure modes, root cause, IFU reminders, and recommendations
• Participate in process improvement activities to continuously improve process effectiveness
• Execute on projects as required
• Perform other duties as directed

Skills and Job Requirements:

Education – English, journalism, or a communications undergraduate degree.  Preferred Undergraduate degree in engineering, life science, or equivalent.  

Experience – Experience with technical writing for a technical product and/or company.  Preferred experience within the medical device field, with experience or exposure in the following areas:

• • • Experience collaborating with engineering, scientists, and other specialists
    • General technical and or clinical medical device knowledge
    • Knowledge and understanding with Medical Device Complaint files and quality record documentation

Skills: The following skills are required for this position:

• Demonstrate strong written and verbal communication skills
• Strong computer skills (SAP, Excel, Word, PowerPoint, database)
• Efficient independent worker with ability to focus
• Attention to detail
• Demonstrate cross functional communication skills in email and in person
• Excellent organizational and analytical skills
• Ability to handle and manage workload independently
• Prioritize numerous activities in a rapid paced environment
• Contribute to team oriented tasks
• Strong analytical skills
• Strong interpersonal and decision making skills.

Competency / Training: The following competencies are essential for this position:

• Having the ability to devote time and energy to the vital activities that will make a significant impact or difference
• General understanding of technical writing and ability to simplify complex topics.
• General understanding of quality records requirements and how they apply to complaint files.
• Able to make decisions quickly using information at hand and evaluate the need to obtain clarification and direction when necessary.

Intuitive es un empleador que brinda igualdad de oportunidades de empleo. Proporcionamos igualdad de oportunidades de empleo a todos los solicitantes y empleados cualificados, y prohibimos cualquier tipo de discriminación y acoso, independientemente de su raza, sexo, condición de embarazo, orientación sexual, identidad de género, origen nacional, color, edad, religión, condición de veterano protegido o de discapacidad, información genética o cualquier otra condición protegida por las leyes federales, estatales o locales aplicables.

Aviso sobre los Controles de Exportación de EE. UU.: De acuerdo con las Regulaciones de Administración de Exportaciones de EE. UU. (15 CFR §743.13(b)), algunos puestos en Intuitive Surgical pueden estar sujetos a controles de exportación de EE. UU. para candidatos que sean nacionales de países actualmente bajo embargo o sanciones.

Cierta información que usted proporcione como parte de la solicitud será utilizada para determinar si Intuitive Surgical necesitará (i) obtener una licencia de exportación del gobierno de EE. UU. en su nombre (nota: el proceso de obtención de la licencia puede tardar entre 3 y más de 6 meses) o (ii) implementar un Plan de Control de Tecnología (“TCP”, por sus siglas en inglés) (nota: normalmente este paso agrega 2 semanas al proceso de contratación).
Para cualquier puesto en Intuitive sujeto a controles de exportación, las ofertas finales están condicionadas a la obtención de una licencia de exportación aprobada y/o a la ejecución de un TCP antes de la fecha de inicio del empleado potencial, la cual puede o no ser flexible, y dentro de un plazo que no obstaculice de manera irrazonable la necesidad de contratación. Si aplica, los candidatos serán notificados e instruidos sobre cualquier requisito relacionado con estos fines.